Clearance Summary
PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS received FDA 510(k) clearance under submission number DEN110016, sponsored by Ethicon Endo-Surgery. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-04-30.
- Submission: DEN110016
- Applicant / Sponsor: Ethicon Endo-Surgery
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4805
- Decision date: 2012-04-30
Classification & Regulation
This clearance is catalogued under FDA product code OXT and 21 CFR 878.4805, within the General, Plastic Surgery review panel as a Class II device.